Limited Source Justification FAR Part 8 (APR 2021) W91YTZ21R0073 Mark for Redaction_Redacted.pdf

(Allergen Testing System and Supplies (Reagents), Fort Gordon, GA

CUI//SP-PROCURE

CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4)

APR 2021

Justification Review Document for Limited Source Justification

Under FAR Part 8

Program/Equipment: Allergen Testing Supplies (Reagents)

Authority: Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6.

Amount:

. This is a supply requirement therefore FAR 52.217-8, “Option to Extend Services Clause” will not be included in the resultant contract.

Prepared by:

Typed Name: Sherina Ross DSN:

Title: Contract Specialist Date: September 15, 2021

E-mail: sherina.l.ross.civ@mail.mil

Contracting Officer:

Typed Name: Sebrena Lane DSN:

Date Reviewed: September 15, 2021 E-Mail: _ sebrena.l.hackleylane.civ@mail.mil

Controlled by: USAHCA Controlled by: RHCO-A CUI Category: SP-PROCURE Limited Dissemination Control: FED ONLY POC: Sebrena Lane, CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4)

Technical Representative:

Typed Name: DSN:

Title: Chief, Microbiology Date Reviewed: September 15, 2021

Requirements Representative:

Title: Contracting Officer Representative Date Reviewed: September 15, 2021

CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4)

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Signature: Date:

Command Advocate for Competition

Typed Name: DSN: (

CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4)

Limited Source Justification

1. Contracting Activity: Regional Health Contracting Activity-Atlantic, Gordon Health

Contracting Branch, 43 Central Hospital Court, Building 332, Fort Gordon, Georgia, 30905.

2. Description of Action: This requirement is for new Firm-Fixed Price contract for the lease of the and Allergen Testing Supplies (Reagents) in support of the Dwight D. Eisenhower Army Medical Center (DDEAMC), Department of Pathology. FY22 Operation and Maintenance, Army funds will be used.

3. Description of Supplies/Services: The vendor will provide two testing analyzer platforms, associated maintenance, reagents, and part/labor for the Microbiology and Immunology Section of the Laboratory. The estimated value of the requirement inclusive of 12 month options is

4. Authority Cited: Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6(a)(1)(i)(B) “Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized”.

5. Reason for Authority Cited: The DDEAMC Department of Pathology Service provides full-reference diagnostic level testing and support services to beneficiaries, civilian and service members. Continuous operation of the is required to sustain patient care and ensure force readiness requirements. This contract will provide equipment (

, reagents and supplies.

(a) The proposed acquisition must be accomplished through a limited sources justification for the following reasons:

1. The equipment is the only product on the market that can sustain patient care at DDEAMC.

2. The current contract will expire and there is no replacement contract in place. The critical need for this service is now, therefore a 06 Priority Designation has been approved to allow time to work this requirement prior to the expiration of the current contract and avoiding a lapse in service. The contractor

CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4) has performed satisfactorily during the current period and the Eisenhower Army Medical Center has a continuing need for their services. Failure to provide the required equipment and supplies would impact the DDEAMC mission and result in diminished care of the patients.

3. This contract will ensure that a reliable back up is available should instrumentation fails to perform at DDEAMC. Additionally, as directed by MEDCOM, a new contract is requested in order to continue the use of the allergen testing.

4. The Department is unable to sustain diagnostic level allergy testing mission requirements without taking known scheduled diverts to LabCorp for specimen testing.

a. The reagents provide a cost-effective means to conduct Allergen testing. If the allergen testing are not selected for specimen testing, the Department of Pathology would require additional funds to ship all specimens to LabCorp and/or suspend operations. No similar panel based products are available to the applicable .

b. An alternative available to the government is to send out specimens to LabCorp. Specimen sent to LabCorp would be cost prohibitive and reporting could take several days, reducing delivery of rapid results to providers and reducing five-star healthcare to our Civilian and Military DDEAMC beneficiaries. Disapproval will increase turnaround times for life threatening disorders.

c. DDEAMC is required to provide a standard of care for in-house and external beneficiaries. The minimum requirement to test agents of concern is required to provide medical providers with the results needed to maximize patient care and treatment. The Department of Pathology anticipates an additional year contract to sustain operations.

(b) Describe the reason for authority cited: FAR 8.405-6(a)(1)(i)(B): “Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized”.

6. Efforts to Obtain Competition: Attempts to locate a suitable source were made through internet searches, General Services Administration (GSA) searches and discussions with the equipment developer resulted in confirmation of the requirements proprietary sole source nature.

a. Effective competition. There is no effective competition expected for this requirement.

This will be a sole source requirement to

CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4)

b. Subcontracting competition. No subcontracting opportunities exist.

7. Actions to Increase Competition: No additional action will be taken to increase competition for this requirement as the vendor has confirmed they are the sole source vendor for the . There is no other product like this available for competition at this time that can be used with our existing testing platforms.

The market will be monitored for changes to sole provider nature of this product and future competition will be based this.

8. Market Research: Market research was conducted in accordance with FAR Part 10 during the period 26 -27 August 2021. is the sole source vendor of the

. Market research consisted of review of Government databases for relevant information. A search of the Quick market Search Listing website was reviewed using NAICS 532490, keyword searches of “Immuno Analyzer” resulted in no additional firms in any of the economic group meeting search criteria.

9. Other Facts:

a. Procurement history.

(1) Contract number: , awarded 02 March 2017

(2) Competitive Status: Unrestricted.

(3) Authority previously cited if less than full and open competition was used. N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. NA

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

b. Other facts. None

CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4)

10. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Typed Name:

Title: Chief, Microbiology

11. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Title:

12. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on price analysis and comparison with IGE validated by market research. This requirement is a commercial service and therefore certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Sebrena Lane Title: Contracting Officer

13. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Sebrena Lane Title: Contracting Officer

CUI//SP-PROCURE

(Source Selection Information - See FAR 2.101 and 3.104-4)

Approval

Based on the foregoing justification, I hereby approve the acquisition for the lease of the and Allergen Testing Supplies (Reagent) for a total estimated value of pursuant to the authority of FAR 8.405-6(a)(1)(i)(B), “Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized”, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Typed Name: Title: Command Advocate for Competition